The algorithm of evaluation of interchangeability of pharmaceuticals
- 作者: Romanov B.1, Sakaeva I.1, Bunyatyan N.1, Vasilyev A.1, Bondarev V.1, Prokofyev A.1, Yagudina R.1, Alyautdin R.1, Kovaleva E.1, Pereversev A.1, Zatolochina K.1, Kazakov A.1, Komratov A.1, Koshechkin K.1, Pasternak E.1
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隶属关系:
- The research center of expertise of means of medical application of Minzdrav of Russia
- 期: 卷 21, 编号 5 (2015)
- 页面: 43-47
- 栏目: Articles
- URL: https://journals.rcsi.science/0869-2106/article/view/38292
- DOI: https://doi.org/10.17816/rmj38292
- ID: 38292
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作者简介
Boris Romanov
The research center of expertise of means of medical application of Minzdrav of Russia
Email: Romanov@expmed.ru
MD, PHD, DSc 127051 Moscow, Russia
I. Sakaeva
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
N. Bunyatyan
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
A. Vasilyev
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
V. Bondarev
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
A. Prokofyev
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
R. Yagudina
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
R. Alyautdin
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
E. Kovaleva
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
A. Pereversev
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
K. Zatolochina
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
A. Kazakov
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
A. Komratov
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
K. Koshechkin
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
E. Pasternak
The research center of expertise of means of medical application of Minzdrav of Russia127051 Moscow, Russia
参考
- Федеральный закон от 22.12.2014 № 429-ФЗ «О внесении изменений в Федеральный закон "Об обращении лекарственных средств"». М.; 2014.
- Сводный отчет о проведении оценки регулирующего воздействия (Цит. по http://regulation.gov.ru/project/22466.html, дата обращения - 12.01.2015).
- Федеральный закон от 12.04.2010 № 61-ФЗ (ред. от 22.10.2014) "Об обращении лекарственных средств" (с изм. и доп.). М.; 2014.
- Лепахин В.К., Романов Б.К., Никитина Т.Н., Снегирева И.И. Экспертиза оценки отношения ожидаемой пользы к возможному риску применения лекарственых средств. Ведомости Научного центра экспертизы средств медицинского применения. 2012; 2: 19-21.
- Truus Janse-de Hoog. Interchangeability of generics. European Medicines Agency. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500107873.pdf. (Accessed 12 January 2015).
- Approved Drug Products with Therapeutic Equivalence Evaluations, 34nd (2014) [Orange Book]. United States Food and Drug Administration / URL: http://www.accessdata.fda.gov/scripts/cder/ob. (Accessed 12 January 2015).
- Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 (Draft Guidance Updated for 508 on 3/22/12). Food and Drug Administration. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm259797.htm. (Accessed 12 January 2015).